FDA 510(k) General & Plastic Surgery Devices
FDA 510(k) General & Plastic Surgery Devices - Regulatory Overview
FDA 510(k) general and plastic surgery devices represent the largest 510(k) category with 18,104 submissions since 1976. The FDA review panel code is SU.
This panel covers a broad range of surgical equipment:
- Electrosurgical units (ESU) - monopolar and bipolar cutting and coagulation
- Surgical lasers - CO2, Nd:YAG, diode and excimer surgical lasers
- Laparoscopic instruments - trocars, graspers, staplers, clip appliers
- Wound care and closure - negative pressure therapy, staples, tissue adhesives
- Aesthetic devices - body contouring, skin resurfacing, fat reduction systems
18288
Total
18243
Cleared
138d
Avg (2y)
1976
Since
14008 General & Plastic Surgery devices
Cleared
Nov 15, 2001
ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND
GEI
Electrosurgical, Cutting & Coagulation & Accessories
28d
Cleared
Nov 14, 2001
SYMPHONY GRAFT DELIVERY SYSTEM (GDS)
GEY
Motor, Surgical Instrument, Ac-powered
90d
Cleared
Nov 14, 2001
TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX
GCJ
Laparoscope, General & Plastic Surgery
89d
Cleared
Nov 14, 2001
VISULAS 532S
GEX
Powered Laser Surgical Instrument
30d
Cleared
Nov 08, 2001
REPROCESSED RF ARTHROSCOPY PROBES
GEI
Electrosurgical, Cutting & Coagulation & Accessories
86d
Cleared
Nov 08, 2001
REPROCESSED LASER PROBE
GEX
Powered Laser Surgical Instrument
86d
Cleared
Nov 07, 2001
PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES
GEX
Powered Laser Surgical Instrument
204d
Cleared
Nov 07, 2001
REPROCESSED HARMONIC
NLQ
Single-use Reprocessed Ultrasonic Surgical Instruments
90d
Cleared
Nov 07, 2001
REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
89d
Cleared
Nov 07, 2001
REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
NUJ
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
86d
Cleared
Nov 07, 2001
VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
85d
Cleared
Nov 05, 2001
SCITON IMAGE HAIR REMOVAL LASER
GEX
Powered Laser Surgical Instrument
89d
Cleared
Nov 01, 2001
W.O.M. LASER U100
GEX
Powered Laser Surgical Instrument
198d
Cleared
Nov 01, 2001
KSEA SIALOENDOSCOPES AND ACCESSORIES
GCJ
Laparoscope, General & Plastic Surgery
87d
Cleared
Oct 30, 2001
CRYO-HIT, MODELS EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, AND EP2T1
GEH
Unit, Cryosurgical, Accessories
88d
Cleared
Oct 30, 2001
VANGUARD REPROCESSED ARTHROSCOPIC WANDS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
77d
Cleared
Oct 26, 2001
BIOPATCH ANTIMICROBIAL DRESSING
SEL
Securement Wound Dressing For Reduction Of Infection
381d
Cleared
Oct 26, 2001
SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45
GDW
Staple, Implantable
65d
Cleared
Oct 26, 2001
MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166
GEI
Electrosurgical, Cutting & Coagulation & Accessories
17d
Cleared
Oct 25, 2001
ARTHROCARE ELECTROSURGERY WANDS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
80d
Cleared
Oct 24, 2001
CONFORM SHEETING, MODEL IGEL
MDA
Elastomer, Silicone, For Scar Management
86d
Cleared
Oct 22, 2001
REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
GEI
Electrosurgical, Cutting & Coagulation & Accessories
70d
Cleared
Oct 19, 2001
POWERPRO BATTERY SYSTEM
HAB
Saw, Powered, And Accessories
88d
Cleared
Oct 12, 2001
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED)
QPB
System, Suction, Lipoplasty For Removal
290d
Cleared
Oct 11, 2001
CRYOCARE SURGICAL SYSTEM
GEH
Unit, Cryosurgical, Accessories
304d
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